SS-EN ISO 14971 : 2012現行
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
出版：Standardiserings-Kommissionen I Sverige
專家解讀視頻
基本信息
標準編號： SS-EN ISO 14971 : 2012
標準類別：Standard
出版單位：Standardiserings-Kommissionen I Sverige
標準頁數：0
標準簡介
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
